Regulatory Affairs Quality Specialist

Akkodis; Irvine (CA); On-site; USD 55,000 - 56,000; Part time

Job summary

Akkodis in Irvine, CA is seeking a Regulatory Affairs Quality Specialist/Engineer for a contract role onsite. The position requires 3–5+ years of experience and supports QMS implementations, regulatory inspections, and cross-functional projects. Pay is competitive and the assignment is 12 months+ with possible extension.

The candidate will manage CAPA, risk management, RCA, and data analysis, and will use Excel, PowerPoint, and visualization tools to report updates to leadership.

Qualifications

• Strong understanding of QMS and regulatory standards (ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, GMP) and their business impact.

Responsibilities

• Implement and maintain QMS per ISO 13485 and applicable regulations.
• Lead CAPA, risk management (ISO 14971), and investigations.
• Support regulatory inspections and internal audits.
• Collaborate cross-functionally on multiple quality/regulatory projects.
• Develop KPIs and provide management with performance insights.

Skills

QMS knowledge

CAPA

Root Cause Analysis

FMEA

Data analysis

KPI development

Project management

Excel

PowerPoint

Data visualization

Cross-functional work

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Microsoft Excel

Microsoft PowerPoint

Data visualization tools

Job description

Akkodis is seeking a Regulatory Affairs Quality Specialist/Engineer for a contract job in Irvine, California, United States, Onsite

Pay Range: $40/hr - $41/hr on W2

(The rate may be negotiable based on experience, education, geographic location, and other factors.)

Job Title : Regulatory Affairs Quality Specialist/Engineer

Duration: 12 Month+(Possible to Extend)

Exp Required : 3-5+ Years

Job Title: Regulatory Affairs Quality Specialist/Engineer

Location: Irvine, CA

Job Summary:

• Strong understanding of Quality Management Systems (QMS) and applicable regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, GMP), and experience in their implementation considering business perspective.
• Proficient in quality tools and methodologies including: CAPA, Risk Management (ISO 14971), Root Cause Analysis, FMEA/PFMEA, Statistical Analysis and Trending, Process Mapping, Fishbone Diagram, 5 Whys, Control Plans, Internal Auditing.
• Experience with data analysis, KPI development, and management reporting.
• Demonstrated experience leading complex quality and regulatory compliance initiatives.
• Experience supporting regulatory inspections, internal audits, and quality management system activities.
• Experience working in cross-functional teams and managing multiple projects simultaneously.Strong project management skills, including planning, execution, risk management, and stakeholder engagement.
• Proficiency with Microsoft Office Suite, especially Excel, PowerPoint, and data visualization tools.

Preferred Training / Certifications like:

• ASQ Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA), or equivalent
• Project Management Professional (PMP) certification or equivalent project management training
• Lean Six Sigma Green Belt or Black Belt
• Internal Auditor and/or Lead Auditor training
• Quality Management System Requirements training (ISO 13485)
• Lead strategic quality and regulatory compliance initiatives.
• Facilitate risk assessments and drive risk-based decision making.
• Analyze quality data and identify opportunities for improvement.
• Support internal and external audits, and regulatory compliance activities.
• Lead complex investigations, CAPAs, and continuous improvement programs.
• Manage cross-functional projects to ensure timely execution and sustainable results.
• Provide quality and regulatory compliance expertise and guidance to business partners and leadership.
• Perform other quality-system duties as assigned.

Education:

• Minimum Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers